BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERT-HANDLE F/PHILOS W/CONNECSCR HEX

    MDR report key: 3160219 · Received June 10, 2013

    Report

    Report Number
    8030965-2013-03035
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    July 20, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE RECEIVED INSERTION GUIDE WAS INVESTIGATED BASED ON THE PRODUCTION AND MATERIAL DOCUMENTS AND IT WAS FOUND THAT ALL STANDARDS WERE MET AND ALL SPECIFICATIONS WERE COMPLIED WITH. BASED ON THE FINDING THAT THE ATTACHMENT SCREW BROKE OFF, WE ASSUME THAT THE DAMAGE IS DUE TO INCORRECT HANDLING OR THAT EXCESSIVE MECHANICAL LOAD AIDED IN THE BREAKING OF THE SCREW. NO PRODUCT DEFECT WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN UNKNOWN SURGERY THAT THE ATTACHMENT SCREW BROKE OFF INSIDE THE PLATE. THE REST OF THE ATTACHMENT SCREW REMAINED IN THE PLATE. THE PLATE WITH THE REST OF THE BROKEN SCREW DID NOT REMAIN IN THE PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260387 INSERT-HANDLE F/PHILOS W/CONNECSCR HEX LXH SYNTHES GMBH 7562760

    Patients

    Seq Age Sex Outcome Treatment
    1